Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress (SITOT)
Aim: The study aim to assess the feasibly a large prospective multi-centre randomised study for comparing the relatively new "Single incision sub-urethral tapes" with the standard surgical treatment of female urodynamic stress incontinence (USI).
Female Stress Incontinence
Procedure: sub-urethral tape (TVT-O)
Other: stand standard mid-urethral sling (TVT-O)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Feasibility of Comparing Two Surgical Treatment of Female Urodynamic Stress Incontinence (SITOT)|
- • Feasibility of the single incision sub-urethral tape to be done under local anaesthesia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Feasibility of the single incision sub-urethral tape to be done under local anaesthesia?
- Number of women approached and declining LA o Number of women in LA group converted to GA
- • Patient-reported Success rates [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Patient-reported Success rates
o Assessed by PGI-I "Very Much Improved/ Much Improved."
|Study Start Date:||November 2009|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Experimental: Single-incision Mini-slings (SIMS- Ajust)
AjustTM has polypropylene fixing anchors (one is fixed and the other adjustable) which are anchored onto the obturator membrane. The pulley like system enables adjustment of the tension once the arms have been anchored. Once in place, the anchors rest at right angles to insertion which is claimed to reduce the chances of anchor dislodgment
Procedure: sub-urethral tape (TVT-O)
Tension free vaginal tape vs. single incision sub-urethral tension free vaginal tape
standared med urethral sling (SMUS)
standard med urethral sling (SMUS)TVT-O, was done as originally described by Deleval et al.
|Other: stand standard mid-urethral sling (TVT-O)|
Single incision tension-free sub-urethral vaginal tapes procedures8 have been recently described in an attempt to avoid the blind passage of the trochars through the groin & the adductor muscles and consequently reducing the incidence & severity of postoperative leg pain. The obvious advantages would be shorter hospital stay, early recovery, early resumption of day to day activities & earlier return to work. A number of small prospective audits and case-series have been presented in international conferences reporting on the safety & outcomes for these procedures. However all these studies were for preliminary reports for proof of concept and therefore the studies populations were 15-70 women with short term follow-up of 2-3 month9-11.These studies have shown low perioperative complication rates: bladder injury 0-1%, vaginal erosion 1-3% & one study showing 1.3% pain at 6 weeks follow-up. The patient reported success rates were 77-93% at 2-3 month follow-up9-12.
- Establish the feasibility of the "Single incision sub-urethral tapes" to be done under local anaesthesia.
- The feasibility of randomisation to the standard surgical treatment TVT-O / TVT.
- To compare the surgical approach in this relatively new procedure against the standard procedures as regard: Peri-operative complication rates, Postoperative pain, Time to discharge from the hospital,
- To compare the outcomes as regard: Patient-reported cure rates, Patient satisfaction, Impact on Quality of life (QoL) and sexual function at 3 month & 1 -year follow-up. The objective cure rates will be assessed at 3 month follow-up.
A pilot prospective randomised study within participating urogynaecology units of the "Scottish Pelvic Floor Network".
Please refer to this study by its ClinicalTrials.gov identifier: NCT01230450
|(Grampian) Aberdeen Royal Infermary|
|Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD|
|Principal Investigator:||Mohamed Abdel-Fattah, MRCOG||University of Aberdeen|